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PHR1343

Sulfadiazine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Sulfadiazine, 4-Amino-N-(2-pyrimidinyl)benzenesulfonamide, N1-(Pyrimidin-2-yl)sulfanilamide

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About This Item

Empirical Formula (Hill Notation):
C10H10N4O2S
CAS Number:
68-35-9
Molecular Weight:
250.28
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823328
EC Number:
200-685-8
Beilstein/REAXYS Number:
6733588
MDL number:
MFCD00006065

Key Documents

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Product Name

Sulfadiazine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

SEEPANYCNGTZFQ-UHFFFAOYSA-N

InChI

1S/C10H10N4O2S/c11-8-2-4-9(5-3-8)17(15,16)14-10-12-6-1-7-13-10/h1-7H,11H2,(H,12,13,14)

SMILES string

Nc1ccc(cc1)S(=O)(=O)Nc2ncccn2

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. S1800000
traceable to USP 1625009

API family

sulfadiazine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

253 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

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Analysis Note

These secondary standards offer multi-traceability to the US and EP primary standards, where they are available.

Application

Sulfadiazine may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

General description

Sulfadiazine is a bacteriostatic drug, that belongs to the class of medication referred as sulfonamide antibiotics. It is generally used in the treatment of cerebral meningitis, pneumonia, staphylococcal and streptococcal sepsis.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAC3953 in the slot below. This is an example certificate only and may not be the lot that you receive.

signalword

Warning

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 2 - Repr. 2

Storage Class

11 - Combustible Solids

wgk

WGK 2

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Sulfonamide antibiotics
Connor EE
Primary Care Update for OB/GYNS, 5(1), 32-35 (1998)
Sulfadiazine
Pharmacopeia, US
United States Pharmacopeia/National Formulary, 4106-4106 (2018)
Determination of the content and the related substances of silver sulfadiazine gel by HPLC
Li Y, et al.
Chinese Journal of Hospital Pharmacy, 24(8), 474-474 (2004)
33 - Antimicrobial Drugs
Synthesis of Essential Drugs, 499-523 (2006)
Development and validation of a stability-indicating HPLC method for the simultaneous determination of sulfadiazine sodium and trimethoprim in injectable solution formulation
Ghanem MM and Abu-Lafi SA
Scientia Pharmaceutica, 81(1), 167-182 (2013)
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